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Home » Topics » Regulatory » CMS

CMS
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Heart scientific overlay

Impulse Dynamics’ 2022 coverage petition for CCM finally surfaces

Jan. 23, 2025
By Mark McCarty
The backlog of requests for Medicare national coverage analyses is a matter of record, but a new analysis highlights how deep that backlog runs. CMS declared it will review a petition from Impulse Dynamics to consider coverage of cardiac contractility modulation, responding to a request the company filed more than two and a half years ago.
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Generic drugs and bottle

Drugsplaining: Teva details price negotiation impact on generics

Jan. 22, 2025
By Mari Serebrov
With more than five dozen generics already tentatively approved for 10 of the drugs selected for the next round of the Medicare Price Negotiation Program, the impact of the negotiations won’t be limited to just the brand drugs.
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Health professional recording info from patient

CMS drafts guidance for use of real-world data in CED studies

Jan. 21, 2025
By Mark McCarty
Regulatory approval for medical products can rely on real-world data (RWD) typically only for expanded indications for use, but payers have been missing in action where this data source is concerned. The U.S. CMS has floated a guidance to facilitate the use of RWD in coverage decisions, providing a long-overdue update to Medicare clinical trial policy.
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Dollar sign inside vial, syringe

CMS’ price negotiations take two: Ozempic, Xtandi among 15 drugs chosen

Jan. 17, 2025
By Karen Carey
In the final days of the Biden administration, the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services (CMS) laid out the latest 15 drugs that are subject to negotiated prices, with Novo Nordisk A/S’ GLP-1 drug Ozempic for type 2 diabetes topping the list, bringing Rybelsus and Wegovy along for the ride because they share the same active ingredient, semaglutide.
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Cardiomems device with dime for scale

Abbott closes Cardiomems coverage saga with Medicare win

Jan. 15, 2025
By Mark McCarty
The Medicare coverage story of the Cardiomems device has a Homeric air about it, spanning nearly a decade starting with an adverse local coverage determination in 2016. Abbott Park, Ill.-based Abbott Laboratories finally brought the story full circle with a successful national coverage determination that gives the device nationwide coverage for Medicare patients without the need to wrangle with Medicare administrative contractors.
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Recor Medicaal Paradise renal denervation catheter

CMS opens national coverage analysis for renal denervation

Jan. 14, 2025
By Mark McCarty
U.S. Medicare coverage of renal denervation (RDN) for uncontrolled hypertension may soon be a fact of life if the manufacturers of these systems have their way. CMS opened a national coverage analysis for RDN, but as is routine practice recently, the agency is asking for comment before posting even a draft coverage memo for this technology.
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Approved label with medical icons, professional

2024 a banner year for US biosimilar approvals

Jan. 9, 2025
By Mari Serebrov
It’s taken nearly a decade for the U.S. FDA to go from zero to 60 in approving biosimilars. Currently, 63 biosimilars have been approved in the U.S., thanks to 18 new approvals in 2024 that stretched the number of biologics referenced by biosimilars from 14 to 17. That’s an all-time record, CDER Director Patrizia Cavazzoni said, as she released the drug center’s annual approval report for 2024.
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CMS logo and website

Congressional disinterest in CMS appropriations likely to persist

Jan. 7, 2025
By Mark McCarty
The discussion about taxpayer appropriations for CMS has been ongoing for decades, leading to futile speculation regarding user fees for the agency. Louis Jacques, who formerly worked at CMS, told BioWorld that Congress tends to be somewhat reactive when it comes to appropriations for CMS – a dynamic which suggests that appropriations for CMS are not likely to improve significantly in the near term.
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U.S. White House

President-elect: Trump 2.0 health reforms not that ‘radical’

Jan. 2, 2025
By Mari Serebrov
As investors and industry alike try to read the tea leaves of what the upcoming change in administrations holds for the U.S., speculation abounds about what Trump 2.0 will mean for the biopharma and med-tech spaces.
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Medicare puzzle
Year in review

Medicare coverage issues abound in 2024

Jan. 2, 2025
By Mark McCarty
The device industry is extraordinarily dependent on administrative activity where Medicare coverage is concerned, and this was exceptionally evident in 2024 when software and digital health coverage policies remained bogged down.
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Previous 1 2 3 4 5 6 7 8 9 … 32 33 Next

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